FDA.reportPublic FDA data

NDC 80425-0108-01 - Tramadol HCL ER

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0108
Requested NDC
80425-0108-01
Package NDCs from labels
80425-0108-2, 80425-0108-1, 80425-0108-3, 80425-0108-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-11-20
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Tramadol HCL ER - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-11-20HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0108-1Tramadol HCLER30 in 1 BOTTLETABLET, EXTENDED RELEASE307
80425-0108-2Tramadol HCLER60 in 1 BOTTLETABLET, EXTENDED RELEASE607
80425-0108-3Tramadol HCLER90 in 1 BOTTLETABLET, EXTENDED RELEASE907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0108TRAMADOL HCL ER (TRAMADOL HCL) TABLET, EXTENDED RELEASE [ADVANCED RX PHARMACY OF TENNESSEE, LLC]7Current NDC, Legacy NDC, 3 package rows20241123_b4cd4b64-7db5-da44-e053-2995a90a8953.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0108-1EA - Each80425-01084732e417-9029-4e51-a84c-54025ecb45d912023-03-13
80425-0108-2EA - Each80425-01086cfc6ff4-1f55-418d-b8c9-a21bde8197f012023-03-13
80425-0108-3EA - Each80425-0108b5c80406-51df-4df5-9bc9-f3bf5c4c6d6112024-12-10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 6 · 112 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx of Tennessee, LLC2e738ced-9cde-e776-e063-6294a90a7e332025-02-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEClinical Solutions Wholesale, LLC728157e2-d153-4ea0-81eb-36599dc7dfda2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.5babcfcf-331b-5db9-e053-2a91aa0aaf892025-02-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol Hydrochloride and AcetaminophenTRAMADOL HYDROCHLORIDE AND ACETAMINOPHENDirect_Rxe8a7c995-e473-ca87-e053-2995a90a5b802025-01-22Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCL ERDirect_Rx09a7af47-423a-1e8b-e063-6394a90a99ef2025-01-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833713
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDirectRxd5685c80-c84d-d0a1-e053-2995a90afc542025-01-21Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEDIRECT RXb3c702f7-0a8c-a52b-e053-2995a90a6df32025-01-17Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833711
unii: 9N7R477WCK
tramadol hydrochlorideTRAMADOL HYDROCHLORIDENuCare Pharmaceuticals,Inc.1e79e1fa-3473-f4a7-e063-6294a90a95762025-01-14Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEProficient Rx LPd7e75fd3-18d1-4370-bb63-c9dd8a2c17192025-01-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDECranbury Pharmaceuticals, LLC1d4af58f-17f3-4cbd-870c-098ace9548722024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCLTRAMADOL HCLAdvanced Rx of Tennessee, LLCaf87fc31-07c2-b1f7-e053-2995a90a499f2024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCbf51a3af-cbc6-3021-e053-2a95a90a80b72024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833711
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCbba287fe-fbf6-65a9-e053-2a95a90a92372024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEAdvanced Rx Pharmacy of Tennessee, LLCf4ea18b0-2cbd-0d42-e053-2995a90a92642024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCf8c5328d-7b47-626e-e053-6294a90a04b32024-12-31Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833713
unii: 9N7R477WCK
Tramadol HydrochlorideTRAMADOL HYDROCHLORIDEQuality Care Products, LLCf79fda81-f09a-4a08-babc-6bd3bb3ee6612024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEQuality Care Products, LLC68484531-f908-473f-a422-f37234de96912024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833711
unii: 9N7R477WCK
TRAMADOL HYDROCHLORIDETRAMADOL HYDROCHLORIDEQuality Care Products, LLC7e421fb6-737c-49b3-b299-50511e281a4d2024-12-19Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
rxcui: 833709
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCc197f4e4-9ea5-562b-e053-2a95a90a975c2024-11-22Boxed warning, Warnings, Adverse reactionsExact identifier
rxcui: 833709
unii: 9N7R477WCK
Tramadol HCL ERTRAMADOL HCLAdvanced Rx Pharmacy of Tennessee, LLCb4cd4b64-7db5-da44-e053-2995a90a89532024-11-20Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA200503
ndc (package): 80425-0108-1
ndc (package): 80425-0108-2
ndc (package): 80425-0108-3
ndc (product): 80425-0108
ndc11 (package): 80425010801
rxcui: 833709
spl id: 2760a808-b074-5887-e063-6294a90a79ae
spl set id: b4cd4b64-7db5-da44-e053-2995a90a8953
unii: 9N7R477WCK

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.